Illuminated suction apparatus

ABSTRACT

An illuminated suction apparatus including a hand-held surgical device combining a high-performance non-fiber optic optical waveguide with suction. This device is useful in a wide array of surgical procedures including open and minimally invasive orthopedics.

CROSS-REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 13/712,029 (Attorney Docket No. 40556-718.501; now U.S. Pat.No. ______), filed Dec. 12, 2012, which is a continuation in part ofU.S. patent application Ser. No. 13/328,773 (Attorney Docket No.40556-718.201; now U.S. Pat. No. 8,568,304) filed Dec. 16, 2011, whichis a non-provisional of, and claims the benefit of U.S. ProvisionalPatent Application No. 61/423,813 (Attorney Docket No. 40556-718.101,formerly 028638-001600US) filed Dec. 16, 2010; U.S. patent applicationSer. No. 13/712,029 (Attorney Docket No. 40556-718.501; now U.S. Pat.No. ______) is also a continuation in part of U.S. patent applicationSer. No. 13/619,574 (Attorney Docket No. 40556-716.301) filed Sep. 14,2012, which is a continuation of U.S. patent application Ser. No.12/616,095 now U.S. Pat. No. 8,292,805 (Attorney Docket No.40556-716.201) filed Nov. 10, 2009; the entire contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

In various surgical procedures, illumination of the surgical field istypically achieved through the use of headlamps and surgicalmicroscopes. There are scenarios in which these illumination sourcesprovide lighting that is either poor in quality or poorly directed. Asan example, during spinal surgery from the lumbar approach, access tothe desired anatomical target area may be achieved through an angledincision on one side of the patient's midline. Light emanating from anoperating microscope is static and may be poorly directed relative tothe angle of surgical access. Conversely, light from a headlamp may beadjusted as a physician tilts or moves his head to redirect the outputbeam, but still may be blocked by various anatomical structures such asthe spinous process or layers of tissue and muscle. Lighting from eithersource may not be adequate as the physician progresses through variousphases of the procedure requiring visualization of the anatomy at varieddepths from the skin-level incision.

Hand-held instruments such as suction devices are routinely used duringsurgical procedures such as spine surgery. These devices are typicallyconnected to a standard suction source in the operating room, enablingthe physician to dynamically and efficiently remove blood, bonefragments, or fluid previously irrigated into the surgical site. Thesesuction devices are sometimes also used to provide low force retractionof fat, muscle, or other structures during the procedure. The surgeonholds the suction device from its proximal end, manipulating the distalportion of the suction device during the surgical procedure in order toprovide suction at the desired location. Hand-held suction devices arewidely available in a variety of distal tip configurations suited tovarious surgical applications (Frazier, Poole, Fukushima, etc).

Conventional suction devices have been constructed with fiber opticcable encased in metallic tubing and connected to metallic ornon-metallic suction devices to provide some level of illumination.These devices face multiple challenges. Inefficiencies in thefiber-to-fiber coupling with high intensity light leads to light lossesat the interface which produces heat. Losses are caused bynon-transmissive zones between the optical fibers and Fresnelreflections at the interface. The spatial zones between the fibers arefrequently the dominant cause of light loss and heat. Excess heat at theinterface can cause thermal damage to the tissues and is also a firehazard in the operating room. Some manufacturers recommend limiting theamount of light that can be transmitted to the operative device andinterface, reducing the inherent heat transmission.

Therefore improved illuminated suction apparatuses are still needed. Atleast some of the challenges described above will be overcome by theembodiments disclosed herein.

SUMMARY OF THE INVENTION

The present invention relates generally to the field of surgicalillumination and more specifically to illumination systems withintegrated surgical tools.

The devices described below provide improved illumination in a surgicalsuction device. The illuminated suction device described below includesa metal or non-metallic suction tube having a proximal end and a distalend connected by a central portion. The proximal end of the suction tubeis provided with fittings for connection to a vacuum source. The suctiontube has an inner surface and an outer surface, with a layer of opticalcladding having a refractive index that may be between 1.29 and 1.67 onthe outer surface of the central section of the suction tube, and anillumination waveguide having a proximal end and a distal end. Theillumination waveguide is formed surrounding the optical cladding on thecentral portion of the suction tube, and serves to conduct light aroundthe suction tube from the proximal end to the distal end of theillumination waveguide. The illumination waveguide may have a refractiveindex between 1.46 and 1.7 and may have a numerical aperture between0.33 and 0.70. An illumination input is formed into the proximal end ofthe illumination waveguide for conducting light from a source to theillumination waveguide.

The illuminated suction apparatus includes suction and illuminationfunctions integrated into a hand-held device suited to meet theergonomic needs of the physician. The hand-held, repositionable suctionfunction already prevalently used in surgical procedures is surroundedby an illuminated waveguide which enables the physician to applylighting directly to the desired region of the anatomy below the skinregardless of incision angle, depth, and surrounding anatomicalobstructions. The illumination waveguide is a solid structure designedto specifically guide light from a high-intensity light source and isfabricated using injection molding of an optical-grade polymer with aspecific index of refraction such as cyclo-olefin polymer or copolymeror any other suitable acrylic or plastic. Furthermore, the illuminationwaveguide can be engineered to efficiently transmit light from itsdistal output by sheathing or surrounding it with a second material oflower index of refraction properly coordinated to the index ofrefraction of the core material to preserve Total Internal Reflection(TIR). This solid-state, structure guided illumination waveguide ispowered via a fiber optic cable connected to a high intensity lightsource such as 300 W xenon sources supplied by Luxtec, BFW, and others.

The illuminated suction apparatus may also include one or more barbs,ridges or other protrusions on the proximal end of the suction lumenenabling the connection of standard PVC surgical tubing or othersuitable vacuum conduit.

The use of a generally solid waveguide for suction illumination, ratherthan optical fibers, eliminates losses due to the non-transmissivespaces between the optical fibers and reduces losses solely to thoseassociated with Fresnel reflections. The marked reduction in lossesassociated with a fiber/fiber junction allows for high intensity lighttransmission to the waveguide without significant heating of theinterface or need for heat sink devices or mechanisms at the interface.With a fiber to waveguide connection, light from a standard 300 wattlight source can be transmitted with use of standard connectors such asACMI, with a steady state temperature below the temperatures harmful tobody tissue without design alteration. In some embodiments, a pigtailconnector may be used to introduce light into the waveguide. The pigtailis a flexible optical input that is attached to a proximal portion ofthe waveguide. It may be a bundle of optical fibers, or a singleflexible light pipe. The pigtail may be received in one or morereceptacles on the proximal portion of the waveguide and bonded to thewaveguide with an optical index matching adhesive. In other embodiments,the pigtail may be may be formed by overmolding the waveguide around thepigtail into a single integral part. The pigtail may flare outward tomatch the width of the proximal portion of the waveguide so that lightis more evenly introduced into the waveguide. In still otherembodiments, the pigtail may be used to provide other services to thedevice such as suction or electrical current. For example, the pigtailmay be a flexible cable having multiple lumens. A lumen may be used tohold one or more optical fibers for delivering light to the waveguide,while another lumen may be used to provide suction to the suction tubeinstead of having a separate suction tube. In some embodiments, a lumenmay be used to house one or more electrical conductors that supplycurrent to the suction tube or electrodes when the device is used todeliver current to the tissue, or when the light source is a part of thedevice. The pigtail may have any combination of these features and isadvantageous since it reduces the total number of cables required andalso helps keep device profile reduced.

Use of total internal reflection and light mixing in an illuminationwaveguide (also referred to herein as an optical waveguide) enablescontrol of the output light profile and enables custom illuminationprofiles. Microstructures such as facets, lenses and or lens arrays canbe applied to any suitable surfaces of the illumination waveguide andlight can be extracted incrementally along the walls of the device withinjection molded structures and other suitable structures at minimaladded cost. Use of sequential extraction surfaces, changes in thenumerical aperture of the device as a function of position, use ofextraction structures—either micro or macro structural, with or withoutchanges in the numerical aperture, selective cladding, selectivereflective coatings, etc, all can be used to shape the output profile ofthe waveguide to meet the design specifications or light specificationsrequested by the user for specific surgical suction illuminationapplications.

The device is meant to be disposable, fabricated out of low costmaterials to enable leverage of manufacturing efficiencies through useof processes such as high-volume injection molding, over-molding, andmetal & polymer extrusion. Device assembly would be engineered tominimize labor costs. A low cost, high-performance combination deviceprovides an attractive alternative to existing discrete illumination andsuction devices while minimizing incremental cost to the user.

The illuminated suction apparatus comprises a hand-held surgical devicecombining a high-performance illumination waveguide with suction. Thisdevice would be useful in various surgical procedures including open andminimally invasive orthopedics. The illumination waveguide may also becombined with other surgical devices such as surgical drills and probes,etc. The illumination waveguide may be fabricated with fiber opticpigtails, index matching liquid and or suction lumens.

The surgical suction field must be illuminated by the illuminationwaveguide while the distal suction tip is in active contact with thetissue and or fluid surface. To achieve this effect, the output lightfrom the illumination waveguide must emanate from a point on thewaveguide that is proximal to the distal suction tip of the device.Where the design configuration requires the light to exit from thewaveguide proximal to the distal tip of the surgical tool, the waveguideshape may be configured to control the numerical aperture of thewaveguide and thus, the divergence angle of the exiting light.Similarly, one or more refraction elements such as lenses of anysuitable size may be formed in or near the distal end of the waveguideto control the light emitted from the waveguide. In surgery, when usinga suction illumination device in which the output light emanates from apoint proximal to the distal end of the device, a surgeon may experiencedifficulty due to glare from the distal tip. Thus, a light source suchas an LED may be positioned adjacent the distal end of the device, orthe light source may be adjacent the proximal end of the device such asin the handle, while in still other embodiments, an external lightsource is utilized.

In an alternate configuration, the distal tip of the suction tube may beconfigured to transmit light or reflect light such that the surgeon seesthe distal tip of the suction as illuminated such that he/she canlocalize the distal tip of the suction device in their peripheral visionwithout directly looking at or focusing on the tip of the device.Extending a thin layer of the waveguide to the tip can provide theeffect. Strategies that implement this effect include but are notlimited to: (a) waveguide extended to the tip with or without surfaceextraction features to cause light to back reflect or scatter off thetip, (b) Use of a thin layer of optically transmissive material withhigh scattering coefficient to cause the suction device to glow (c)reflective surfaces applied to the outside of the central suction device(d) reflective surfaces applied with imperfections on the surface toreflect or scatter the light off the outer surface (e) use of a claddingmaterial applied to the walls of the inner suction tube that transmitsor scatters a portion of the output light, the input to the claddingbeing either an imperfection in the cladding or naturally occurringleakage, (f) fluorescent coating on the tip, (g) phosphorescent coatings(h) use of embedded or graded reflectors along or at the tip of thedevice. Alternatively, the distal tip geometry could be formed tointentionally scatter light (square edges, etc).

One or more surfaces in an optical waveguide sheath or adapters orconnectors may be polarized using any suitable technique such asmicro-optic structure, thin film coating or other coatings. Use ofpolarized light in a surgical environment may provide superiorillumination and coupled with the use of complementary polarizedcoatings on viewing devices such as cameras or surgeon's glasses mayreduce reflected glare providing less visual distortion and moreaccurate color rendering of the surgical site. One or more surfaces ofan optical waveguide sheath may also include light filtering elements toemit light of one or more frequencies that may enhance visualization ofspecific tissues.

In a first aspect of the present invention, an illuminated suctiondevice comprises a suction tube having a proximal end, a distal end, anda central portion therebetween. The proximal end is fluidly connectableto a vacuum source, and the suction tube further comprises an innersurface and an outer surface. An inner layer of optical cladding isdisposed circumferentially around the outer surface of the centralportion of the suction tube, and the device also includes a non-fiberoptic optical waveguide. The optical waveguide has a proximal end, adistal end, and a central portion therebetween. Light is transmittedthrough the waveguide by total internal reflection and the light exitsthe distal end of the optical waveguide to illuminate a surgical field.The optical waveguide is disposed against the suction tube with theinner layer of optical cladding disposed therebetween. The device alsomay have an outer layer of optical cladding disposed circumferentiallyaround the suction tube and the optical waveguide.

The suction tube may comprise a tube having a cylindrically shapedcross-section. Other cross-sections such as D-shaped, or rectangularshaped may also be employed. The distal end of the suction tube may bedisposed further distally than the distal end of the optical waveguide.The device may further comprise a suction control mechanism disposednear the proximal end of the suction tube. The suction control mechanismmay be adapted to control strength of suction provided by the suctiontube. The suction tube may also be electrically conductive and may actas an electrode for conducting an electrical signal. A distal portion ofthe suction tube main remain free of cladding. A portion of the suctiontube may remain unobstructed by the optical waveguide.

The inner layer of optical cladding may have an index of refractionbetween 1 and 1.42. The inner layer of optical cladding may form a tubehaving a substantially circular cross-section. The inner layer of theoptical cladding may be concentric with the suction tube.

The optical waveguide may have a refractive index between 1.46 and 1.70.The optical waveguide may have a numerical aperture between 0.33 and0.7. The distal end of the optical waveguide may comprise an array oflenses integrally formed in the distal end thereof. The array of lensesmay be arranged so that at least a first lens overlaps with a secondlens, and such that a spot of light emitted from the first lens overlapswith a spot of light emitted from the second lens. The distal end of theoptical waveguide may comprise a plurality of microstructures forextracting light therefrom and the microstructures may be adapted todirect the extracted light to form a pre-selected illumination pattern.The optical waveguide may comprise one or more light extractingstructures near the distal end of the waveguide and the light extractingstructures may be disposed on an outer surface of the optical waveguide.The light extracting structures may be adapted to extract light from theoptical waveguide and they may be adapted to direct the extracted lightlaterally and distally away from the optical waveguide to form apre-selected illumination pattern.

The optical waveguide may have an inner curved surface and an outercurved surface, and the inner curved surface may have a radius ofcurvature different than that of the outer curved surface. An air gapmay be maintained between the suction tube and the optical waveguide.Standoffs may be disposed on the suction tube or on the opticalwaveguide in order to prevent engagement of the suction tube and theoptical waveguide. This helps to maintain the air gap between thesuction tube and optical waveguide. The optical waveguide may comprise apolarizing element for polarizing light exiting the distal end of theoptical waveguide. The distal end of the optical waveguide may not beflat. Similarly, the optical waveguide may also have a filter elementfor filtering light so that one or more wavelengths of light aredelivered to the illumination area. In some embodiments, a barrier maybe disposed between the waveguide and the suction tube and the barrierprevents fluids such as blood from wicking or otherwise traveling alongthe space between the waveguide and suction tube.

The outer layer of optical cladding may have a refractive index between1.29 and 1.67. The outer layer of optical cladding may form a tube thatis non-concentric with the suction tube. A portion of the outer layer ofoptical cladding may directly contact a portion of the inner layer ofoptical cladding. In still other embodiments, a layer of air may bedisposed over a portion of the outer surface of the optical waveguide toform an outer layer of air cladding.

The device may further comprise a light conducting conduit that isintegrally formed as a single piece with the proximal end of the opticalwaveguide, and the light conducting conduit may be adapted to introducelight from a light source into the optical waveguide. The lightconducting conduit may comprise two light conducting conduits eachhaving substantially rectangular cross-sections. The two lightconducting conduits may be integrally formed as a single piece with theproximal end of the optical waveguide. The optical waveguide may beslidably coupled with the suction tube. Therefore, proximal movement ofthe optical waveguide relative to the suction tube increases spot sizeof the light exiting the distal end of the optical waveguide. Also,distal movement of the optical waveguide relative to the suction tubedecreases spot size of the light exiting the distal end of the opticalwaveguide. The device may further comprise a handle coupled to theproximal end of the optical waveguide and the proximal end of thesuction tube. An air gap may be disposed between the waveguide and aninner surface of the handle. Standoffs may be disposed on an innersurface of the handle or on an outer surface of the optical waveguide inorder to prevent engagement of the handle and optical waveguide, therebyhelping to maintain the air gap therebetween.

In still other embodiments, the waveguide may be a molded componenthaving an elongate channel or lumen. The channel or lumen may be used toapply the suction through the waveguide and thus a separate suction tubeis not required.

In another aspect of the present invention, a method of illuminatingtissue in a surgical field of a patient comprises providing anilluminated suction apparatus having a suction tube and a non-fiberoptic optical waveguide that transmits light therethrough by totalinternal reflection. The suction tube and optical waveguide are coupledtogether to form a single handheld instrument. The method also comprisespositioning a distal end of the illuminated suction apparatus in thesurgical field, and illuminating the surgical field by extracting lightfrom the optical waveguide. Light extraction features disposed on adistal end or an outer surface of the optical waveguide are used toextract the light, and also to direct the extracted light to form apre-selected illumination pattern in the surgical field. Whileilluminating the surgical field, fluid or debris may be suctioned fromthe surgical field with the suction tube.

The illuminated suction apparatus may comprise an inner layer of opticalcladding that is disposed around the suction tube. The inner layer ofoptical cladding may be disposed between the suction tube and theoptical waveguide. An outer layer of optical cladding may be disposedaround both the suction tube and the optical waveguide.

The distal end of the illuminated suction apparatus may be positionedinto engagement with the tissue while a distal end of the opticalwaveguide does not engage the tissue. A distal end of the opticalwaveguide may comprise an array of lenses integrally formed therein.Illuminating the surgical field may comprise projecting a spot of lightfrom each lens in the array such that at least a first spot of lightoverlaps with a second spot of light in the surgical field. Illuminatingthe surgical field may also comprise extracting light from the opticalwaveguide with one or more light extracting structures. The extractedlight may be directed laterally and distally away from the opticalwaveguide. Illuminating the surgical field may comprise illuminating thesurgical field with polarized light. Illuminating the surgical field maycomprise filtering light delivered by the waveguide so that one or morewavelengths of light are delivered to the surgical field.

The method may further comprise controlling suction strength provided bythe suction tube with a suction control mechanism. The method may alsocomprise stimulating the tissue with electrical current delivered by thesuction tube. The optical waveguide may be slidably positioned relativeto the suction tube thereby allowing an increase or decrease in spotsize of the extracted light on the tissue.

In still another aspect of the present invention, a method ofmanufacturing an illuminated suction apparatus comprises providing asuction tube having a proximal end, a distal end, a central sectiondisposed therebetween, an inner surface and an outer surface, andproviding a non-fiber optic optical waveguide having a proximal end, adistal end, and an outer surface. The optical waveguide transmits lighttherethrough by total internal reflection. An inner layer of opticalcladding is fit over the outer surface of the central section of thesuction tube, and the optical waveguide is coupled with the suction tubewith the inner layer of optical cladding disposed therebetween. An outerlayer of optical cladding is fit over the outer surface of the suctiontube and over the outer surface of the optical waveguide.

The suction tube may comprise a tube having a circular cross-section.The optical waveguide may have a first curved side with a first radiusof curvature and a second curved side with a second radius of curvature.The first radius of curvature may be different than the second radius ofcurvature. Fitting the inner layer may comprise heat shrinking the innerlayer onto the suction tube. Coupling the optical waveguide with thesuction tube may comprise disposing the suction tube in an elongatedopen or closed channel disposed along the optical waveguide. Fitting theouter layer may comprise heat shrinking the outer layer onto the suctiontube and the optical waveguide.

In yet another aspect of the present invention, a hand held illuminatedsuction device comprises a suction tube, a non-fiber optic opticalwaveguide and optical cladding. The suction tube has an inner surface,and outer surface, a proximal portion and a distal portion. The proximalportion is configured to be fluidly coupled to a vacuum source, and thedistal portion is configured to remove fluid or debris from a surgicalfield. The non-fiber optic optical waveguide has an outer surface, aproximal region and a distal region. The optical waveguide is disposedover the outer surface of the suction tube, and light is transmittedfrom the proximal region of the optical waveguide toward the distalregion thereof by total internal reflection. The light is emitted fromthe distal region of the optical waveguide and directed distally toilluminate the surgical field. The optical cladding is disposed over theouter surface of the optical waveguide and prevents or minimizes contactbetween the optical waveguide and the fluid, the debris, or tissue inthe surgical field. Thus, the optical cladding promotes total internalreflection of the light transmitted through the optical waveguide. Theone or more standoffs are disposed between the optical waveguide and thesuction tube, and they prevent engagement between a portion of thesuction tube with a portion of the optical waveguide thereby maintainingan air gap therebetween. The air gap facilitates total internalreflection of the light through the optical waveguide.

The device may also have a suction hole and a plurality of fins that areboth adjacent the distal portion of the suction tube. The plurality offins may be configured to prevent the tissue in the surgical field fromoccluding the suction hole. The suction tube may conduct electricity,and thus the suction tube may act as an electrode for delivering currentto the tissue in the surgical field without requiring separateelectrodes. Additionally, when the suction tube serves as the electrode,because it is conductive, conductor wires may not be required to runalongside the entire suction tube since the conductor wire may becoupled to a proximal portion of the suction tube. Any portion of thesuction tube may be insulated with a non-conductive layer such as heatshrink so that the current exits the suction tube only at a desiredpoint along the suction tube. Furthermore, if the suction tube ismalleable, it may be bent or otherwise deformed into any desired shapeto deliver suction, illumination, and/or current to a desired positionin the surgical field. One or more electrodes may be coupled to thesuction tube. The electrodes may be configured to deliver current to thetissue in the surgical field.

The optical waveguide may have a cross-section that changes from theproximal region thereof toward the distal region thereof. The opticalwaveguide may have a width and a thickenss and the width may increase ordecrease from the proximal region thereof toward the distal regionthereof. The thickness may similarly increase or decrease from theproximal region toward the distal region. The illuminated suctionapparatus may have an array of lenses disposed on the distal region ofthe optical waveguide, and the array of lenses may be configured toproject the light into a pattern in the surgical field. The lightprojected from each lens in the array may form an illumination pattern,and the lenses may be arranged to have a pitch so that the illuminationpatterns overlaps with one another. The light may emanate from a regionof the optical waveguide that is proximal of the distal potion of thesuction tube.

The optical cladding may comprise an elongate molded polymer elementthat may be rigid or flexible. The elongate molded polymer element mayhave an elongate concave region that is configured to receive theoptical waveguide. The handle may be disposed over the elongate moldedpolymer element.

The illuminated suction apparatus may further comprise a first handlethat is coupled to the proximal portion of the suction tube and alsocoupled to the proximal region of the optical waveguide. The firsthandle may be ergonomically configured to fit in an operator's hand. Thefirst handle may be disposed around the outer surface of the opticalwaveguide with an air gap disposed therebetween. The air gap promotestotal internal reflection of the light passing through the opticalwaveguide. The device may also have a pistol grip handle that is fixedlyor removably coupled to the first handle. The device may also have acradle that is configured to receive the suction tube. The device mayhave a suction control mechanism that is adjacent the proximal portionof the suction tube. The suction control mechanism may be adapted tocontrol suction strength provided by the suction tube.

In still another aspect of the present invention, a method forilluminating tissue in a surgical field of a patient comprises providingan illuminated suction apparatus having a suction tube and a non-fiberoptic optical waveguide. The suction tube and the optical waveguide arecoupled together to form a single hand held instrument. The method alsoincludes maintaining an air gap between the suction tube and the opticalwaveguide. The air gap promotes total internal reflection of lightpassing through the optical waveguide. Fluid and debris in the surgicalfield are prevented from contacting the optical waveguide by providingan optical cladding disposed over the optical waveguide. The opticalcladding also promotes total internal reflection of the light passingthrough the optical waveguide. The distal region of the illuminatedsuction apparatus is advanced into the surgical field, and the surgicalfield is illuminated with light from the optical waveguide. The light isdirected to the surgical field by an array of lenses disposed on adistal region of the optical waveguide. The directed light forms apre-selected illumination pattern in the surgical field. While thesurgical field is being illuminated, debris or fluid such as blood maybe removed from the surgical field with the suction tube.

The optical cladding may comprise an elongate molded polymer elementthat has an elongate concave region configured to receive the opticalwaveguide. Illuminating the surgical field may comprise positioning thedistal region of the optical waveguide in the surgical field withoutengaging the tissue. Illuminating the surgical field may compriseprojecting the light from each lens in the array into an illuminationpattern, and the lenses may be arranged to have a pitch such that theillumination patterns overlap with one another. Suction strengthprovided by the suction tube may be controlled by providing a suctioncontrol mechanism. Electric current may be delivered from the suctiontube or from one or more electrodes coupled to the suction tube tostimulate the tissue.

These and other aspects and advantages of the invention are evident inthe description which follows and in the accompanying drawings.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of an illuminated suction apparatus.

FIG. 1A is a cross-section view of the illuminated suction apparatus ofFIG. 1 taken along A-A

FIG. 1B illustrates an exemplary embodiment of an illuminated suctionapparatus with electrodes.

FIG. 2 is a close up perspective view of the distal end of theilluminated suction apparatus of FIG. 1.

FIG. 2A is a close up view of a single lens from the lens array of FIG.2.

FIG. 3 is a perspective view of an illuminated suction apparatus with ahandle.

FIG. 4 is a cross section view of the distal end of the illuminatedsuction apparatus of FIG. 3 taken along B-B.

FIG. 4A illustrates an exemplary embodiment of light extraction from alateral surface of the illuminated suction apparatus.

FIG. 5 is a cross section view of an illumination conduit inputaccording to the present disclosure.

FIG. 6 is a side view of an alternate illumination conduit.

FIGS. 6A, 6B and 6C are various cross-section views of the alternateillumination conduit of FIG. 6.

FIG. 6D is a perspective view of access port of the alternateillumination conduit of FIG. 6.

FIG. 7 is perspective view of the illumination input of an alternateillumination conduit.

FIG. 8 is perspective view of the illumination input of anotheralternate illumination conduit.

FIG. 9 is a perspective view of an illuminated suction apparatus with ahandle.

FIG. 10 is a cross section view of the illuminated suction apparatus ofFIG. 8 taken along C-C.

FIG. 11 is a cross section view of the handle of the illuminated suctionapparatus of FIG. 10 taken along D-D.

FIG. 12 is a perspective view of an alternate illuminated suctionapparatus.

FIG. 13 is a perspective view of another alternate illuminated suctionapparatus.

FIG. 14 is another exemplary embodiment if an illuminated suctionapparatus.

FIGS. 14A-14B illustrate exemplary geometries of a waveguide.

FIGS. 15A-15C illustrate an exemplary embodiment of an illuminatedsuction apparatus with an adjustable illumination waveguide.

FIG. 16 illustrates an exemplary cross-section of an illuminatedwaveguide apparatus.

FIG. 17 illustrates another cross-section of an illuminated waveguideapparatus.

FIGS. 18A-18B illustrate another embodiment of an illuminated suctionapparatus.

FIG. 19A illustrates a perspective view of the illuminated suctionapparatus in FIGS. 18A-18B.

FIG. 19B illustrates an alternative embodiment of the illuminatedsuction apparatus in FIG. 19A.

FIG. 19C illustrates a cross-section taken along the line C-C in FIG.19B.

FIG. 19D illustrates a cross-section taken along the line D-D in FIG.19B.

FIGS. 20A-20C illustrate various partial cross-sections of theembodiment in FIG. 19B.

FIG. 21 illustrates a perspective view of the embodiment in FIG. 19Bwith the cladding and optical waveguide removed.

FIG. 22 illustrates the suction tube and cradle of the embodiment inFIG. 19B.

FIG. 23 illustrates the suction tube of the embodiment in FIG. 19B.

FIG. 24 illustrates the cladding of the embodiment in FIG. 19B.

FIG. 25 illustrates an exemplary optical coupling.

FIGS. 26A-26B illustrate an exemplary handle.

FIG. 27 illustrates an exemplary pistol grip handle.

FIGS. 28A-28D illustrate various light inputs to the waveguide.

FIG. 29 illustrates an alternative embodiment of an illuminated suctionapparatus.

FIGS. 30A-30D illustrate exemplary embodiments of electrode tips.

FIGS. 31A-31B illustrate an exemplary embodiment of an illuminated andmalleable suction device.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1, 1A, 2 and 2A, illuminated suction apparatus 10includes suction tube 12 enclosing a suction lumen 12L. The suction tubein this embodiment or any of the embodiments disclosed herein may bemade of any suitable material such as a metal like aluminum, stainlesssteel, or polymers such as acrylic, ABS, PVC, and the like. Thecross-section of this suction tube or any suction tubes disclosed hereinmay be circular, non-circular, D-shaped, rectangular, oval, or any othergeometry may be used. Illumination waveguide 14 is secured over claddinglayer 15 on central portion 12A of suction tube 12 leaving input orproximal portion 12P and distal portion 12D exposed. Illuminationwaveguide 14 may have one or more sides, surfaces or other portions thatare configured such as flat side 14S or side 14T to optimize lightmixing as light 11L travels from illuminator input end 14P to exitthrough light output face, or distal face 14F on output end 14D.

Illumination waveguide 14 is made of an optical grade engineeringthermoplastic such as cyclo olefin polymer which efficiently transmitslight. Any other suitable material such as Cyclic Olefin Copolymer,Polycarbonate, Acrylic and or TPC may also be used. Thus, the waveguideis preferably a single piece, formed from a homogenous material. It mayalso be flexible or rigid and self-supporting and thus is not a fiberoptic which is unable to support itself. The angles and bends of thewaveguide structure are engineered so light transmits through thewaveguide via total internal reflection (TIR). The side walls and otherfeatures have angles and flat areas such that light is mixed and notallowed to escape until it reaches the distal end 14D of the waveguideand exits with a selected uniformity. Light that is reflected by TIR isinternally reflected with high efficiency (nearly 100% efficiency).Suction tube 12 introduces a curved interface with illuminationwaveguide 14 that changes the angle of reflection and creates unwantedscatter of the light. Thus an uncoated or untreated suction tube willcause a small portion of light to be lost to absorption and orscattering at each reflection, ultimately resulting in poor lighttransmission efficiency. In order to preserve TIR through the waveguide,cladding material 15 with a specific index of refraction is placedbetween the suction tube and the waveguide. TIR can also be potentiallydisrupted by blood or foreign matter from the surgical site coming intocontact with exterior exposed surface 14X of illumination waveguide 14.Exterior cladding layer 15X having a specific refractive index can alsobe attached to the outside of the waveguide. The waveguide material mayor may not completely surround suction tube 12 in order to provide anillumination pattern from distal end 14D unobstructed by a shadow fromthe metallic or malleable plastic suction tube. The waveguide andTIR-preserving materials are chosen to provide an optimized light exitangle, total light output, and illumination suited to properly visualizethe surgical site. Suction tube 12 could be treated (for exampleanodized in the case of aluminum) in order to reduce glare orreflections resulting from interaction with light output from theilluminator.

FIG. 1B illustrates an alternative embodiment of an illuminated suctionapparatus 10A having electrodes. One or more electrodes 13 e may bedisposed on a distal portion of the suction tube 12, and/or one or moreelectrodes 15 e may be disposed on a distal portion of the waveguide 14.The electrodes allow the illuminated suction apparatus to be used as aprobe for stimulating various tissues such as nerves, or for cauterizingtissue. Wires or other conductors may couple the electrodes to theproximal end of the illuminated suction apparatus 10A which may then maybe coupled with an energy source that provides the current delivered byelectrodes 13 e or 15 e. The electrodes may be attached to the outersurface of the suction tube, or a portion of the outer cladding 15 maybe removed to allow the metal suction tube to be exposed and used as anelectrode. Thus, the suction tube itself may be used as a conductor andelectrode. Similarly, electrodes may be attached to the outer surface ofthe waveguide, or a portion of the cladding 15X may be removed to allowportions of the waveguide to be exposed and used as an electrode ifconductive, or the electrodes may be coupled to the waveguide. Theilluminated suction apparatus may then be operated in monopolar orbipolar mode.

FIGS. 30A-30D illustrate other exemplary embodiments of electrode tipsthat may be formed into the suction tube. For example, FIG. 30Aillustrates suction tube 3002 having a rectangular shaped electrode3004A extending distally past the distal edge of the suction tube. Thewidth of the electode 3004A may be the same width as the suction tube,or it may be greater or less. Additionally, the length of the electrodemay be varied as required. For example, FIG. 30B illustrates a similarrectangular shaped electrode 3004 b but that extends distally away fromthe suction tube less than the previous embodiment. FIG. 30C illustratesan electrode 3004 c that is narrower than the suction tube 3002 and itmay be trapezoidally shaped, while in FIG. 30D, the electrode 3004D istriangular shaped. The electrodes may be formed by removing materialfrom the suction tube so that a single piece, integral device is formed,or the electrodes may be welded or otherwise attached to the suctiontube.

In an alternate configuration, distal face 14F of waveguide 14 mayinclude any suitable surface treatment to control how light 11L formsillumination pattern 19. One or more lenses, or lens arrays such as lensarray 24 may be formed on distal face 14F. Suitable optical featuressuch as lens array 24 may include lenses of identical, similar ordifferent shapes and sizes to produce the desired illumination patternor patterns. Combinations of lens shapes and radii may be used tooptimize lens arrangement on the distal or output face of the waveguide.The lens array may include lenses on any portion of distal face 14F.Distal face 14F is generally planar and may be described with respect toorthogonal axes 26X and 26Y. Individual lenses of lens array 24 may alsobe oriented differently, i.e. have a different pitch, relative to planaraxes 26X and 26Y. In one exemplary embodiment, a plurality of lenses isdisposed on the distal face 14F. Light is projected from each lensdistally toward the surgical field in an illumination pattern. The pitchof the lenses may be adjusted such that the illumination patterns arediscrete and separate from one another, or the pitch of the lenses maybe adjusted such that the illumination patterns overlap with oneanother. Overlapping illumination patterns help eliminate non-uniformillumination that results from optical defects in the lenses and/orwaveguide. Optical defects may be caused by parting lines, gates,scratches, etc. in the optical waveguide and lenses. By overlappingillumination patterns, the non-uniformities are “covered up” or “washedout” by other illumination patterns provided by adjacent lenses in thelens array. Additional details about this feature are disclosed below.

Individual lenses such as lens 24A may adopt any suitable geometry andmay be curved or faceted with one or more facets such as facets 25.Polygonal shapes such as lens 24A allow the lenses to be locatedimmediately adjacent to each other eliminating undirected light leakagebetween the lenses.

In still other embodiments, the distal end of the waveguide may be flator it may be curved (convex or concave) in order to help shape anddirect light to the surgical field. Polarizing elements or filters mayalso be coupled to the distal end so that the waveguide deliverspolarized light to the surgical field which may be advantageous inpreferentially visualizing certain tissues. The polarizing elements mayalso be a wire grid polarizer.

FIG. 14 illustrates another exemplary embodiment of an illuminatedsuction apparatus 1400. The illuminated suction apparatus 1400 includesan illumination waveguide 1410 disposed adjacent a suction tube 1402.The suction tube may be formed of malleable metal or another malleablematerial such that it has a straight relatively rigid distal section1402 r, and a pre-bent flexible proximal section 1402F. The suction tube1402 may be joined to a flexible tubing 1406 that fluidly connects thesuction tube 1402 to a vacuum source (not illustrated) and thus thedistal tip 1404 of the suction tube 1402 may be used to remove fluid orother material from the surgical field. Illumination waveguide 1410 ispreferably a non-fiber optic waveguide (preferably as are any of thewaveguides described herein). The waveguide may be cylindrical asillustrated in FIG. 14, or it may have other profiles such as a squarecross-section, rectangular, oval, elliptical, ovoid, etc., or any of theother geometries described herein. The pre-bent malleable section 1402allows a surgeon or other operator to bend the suction device so that itcan access various surgical sites and accommodate differing anatomies.Another possible cross-section for the illumination waveguide isillustrated in FIGS. 14A-14B where the height h of the waveguide 1410Atapers down such that the proximal end is higher than the distal end.Also, the width of the waveguide 1410A may also increase from theproximal end to the distal end as seen in FIG. 14B. This geometryresults in a trumpet shaped waveguide having a lower profile so that itmay fit in a smaller incision and take up less space in the surgicalfield.

In the embodiment illustrated in FIG. 14, the illumination waveguidetherefore has a flat upper surface and a flat lower surface, as does thesuction tube 1402. Therefore, the bottom surface of the illuminationwaveguide lays flush against the upper surface of the suction tube. Anouter sheath 1414 such as heat shrink may then be used to hold theillumination waveguide and suction tube together. The outer sheath 1414may be selected to have desirable optical properties in order tominimize loss of light. For example, FEP heat shrink has a desirableindex of refraction so that light is transmitted along the waveguide1410 and then extracted from the distal portion 1412 using any of theextraction features described herein. The outer sheath 1414 may also bea tight fitting polymer sheath that is stretched over the waveguide andsuction tube, and may not be heat shrink tubing. Additionally, aseparate layer of cladding such as heat shrink tubing or tightly fittingtubing (not illustrated) that can be stretched may be disposed over thesuction tube in order to minimize light loss caused by contact betweenthe suction tube and the illumination waveguide. The separate layer ofcladding may be FEP tubing or any of the other materials describedherein, and preferably is disposed entirely around the circumference ofthe suction tube. A fiber optic cable 1408 couples the illuminationwaveguide with an external light source (not shown). The fiber opticscable in this embodiment is preferably integral with the waveguide (e.g.injection overmolded together) so as to be fixedly connected to oneanother. In alternative embodiments, the fiber optic cable is releasablyconnected to the waveguide. By joining the fiber optic cable 1408 to thewaveguide near the connection point between the suction tube andflexible tubing 1406, allows the surgeon or operator to easily flex orotherwise manipulate the suction tube without interference from thefiber optic cable. The fiber optic cable 1408 may be coupled with thewaveguide 1402 such that when the malleable bent portion 1402 is bent,the fiber optic cable 1408 bends with the suction tube 1402F, or inother embodiments, the fiber optic cable 1408 need not be coupled withthe bent malleable portion 1402F and may hang freely and independentlyof the suction tube.

In any of the embodiments disclosed herein, the waveguide position alongthe suction tube may be adjustable. For example, in FIG. 15A illuminatedsuction apparatus 1500 includes an illumination waveguide 1502 coupledto a fiber optic cable 1504. The illumination waveguide 1502 is slidablydisposed over suction tube 1506 which is connected to flexible vacuumtubing 1508. The waveguide may slide proximally or distally relative tothe suction tube 1506 and this permits regulation of light output spotsize and brightness in the surgical field. In FIG. 15B, the waveguide1502 is advanced distally relative to the suction tube 1506 therebyresulting in a smaller spot of light 1510 and a more brightly lit distaltip of the suction tube and surgical field. In FIG. 15C, theillumination waveguide is retracted proximally relative to the suctiontube and thus the light spot size 1510 is larger and more diffuse thanin FIG. 15B and therefore less brightly lighting up the distal tip ofthe suction tube as well as less brightly illuminating the surgicalfield. The waveguide 1502 in FIG. 15A may have a circular cross-sectionor it may have other cross-sections such as flat, curved, rectangular,or any of the cross-sections disclosed herein. In some embodiments, thewaveguide has a concave inner surface that forms a saddle for receivingthe suction tube, and a convex outer surface. This allows the waveguideto be mated with the suction tube with a low profile, as discussedherein with respect to FIG. 16.

Referring now to FIG. 3, Light 11L from light source 11 is conducted tothe illumination waveguide using any suitable apparatus such as fiberoptic cable 11C and is then conducted through waveguide 14 and exitsfrom any appropriate structure or structures on or near distal end 14Dof the waveguide. Alternatively, in this or any embodiment herein, thelight source, such as an LED could be integrated into the suction handleeliminating the need for a fiber optic connection, or the LED may bedisposed distally, adjacent the distal tip of the device. Vacuum fromsuction source 13 is conducted to illuminated suction apparatus 20 usingany suitable suction tube such as tube 13T which is connected to vacuuminput 22P. The vacuum available at the distal end of suction tube 12 maybe controlled by covering all or a portion of suction hole H in handle22.

Illuminated suction apparatus 10 may be integrated into a handle such ashandle 22 made of relatively low-cost engineering plastic such as ABS orpolycarbonate. Handle 22 may be formed from two or more components thatcould be separate injection molded components designed to be snap fit,glued, or ultrasonically welded together. Alternatively, the handlecould be formed over an illuminated suction apparatus such as apparatus10 through an over-molding process. The proximal portion of the combineddevice such as illuminated suction apparatus 20 would also contain ahole, hole H, properly positioned to allow the surgeon to enable thesuction function by obstructing all or a portion of the hole with afinger; the hole communicates with the suction pathway in the device,disabling suction by creating a “suction leak” when it is not blocked.Varying the hole geometry, as in the case of Fukijima suction, affordsfiner modulation of the suction function. The proximal end of handle 22may also contain inputs for a traditional fiber optic cable to beattached to illumination waveguide 14, such as a male ACMI connection orother suitable connector, and a vacuum port such as vacuum port 22Pwhich may be a barbed fitting suitable for standard flexible suction PVCsuction tubing of various sizes to be attached. The fiber optic cable isattached to a high-intensity light source such as light 11. Suction tube13T is attached to any standard vacuum source in the OR such as a wastecollection container with integrated vacuum pump such as vacuum source13.

Referring now to FIG. 4, light beam 11B exits waveguide distal face 14Fat a specific angle based on the optical properties such as thenumerical aperture (NA) of the input source, index of refraction of thematerial, and shape of the waveguide. Light pattern 19 cast onto thetarget surgical field is optimized based on the specific distance 16 theilluminator is set back from the distal tip 12D of the suction tube. Fora given light source configuration, divergence angle 18 of light beam11B results in a specific illumination pattern 19 with a total lightoutput and illumination size 17 at any target plane normal to theilluminator such as plane 21. The plane at the distal tip of the suctiontube is of particular interest, since the physician will place thedistal tip at the desired surgical target to enable suction or retracttissue.

FIG. 4A illustrates an alternative embodiment of an illuminated suctionapparatus having light extraction features 23 on a lateral surface ofthe illumination waveguide that extract light 25 and direct the light 25laterally and distally toward the surgical field. This may feature maybe used alone or in combination with the distal features previouslydescribed above. The extraction features may include prisms, lenses,lenslets, multiple facets, or other surface features known in the artthat extract light from the waveguide and direct the light to a desiredarea in a desired pattern. The extraction features may be disposed in adiscrete area to extract light only from that area, or the extractionfeatures may be disposed circumferentially around the waveguide so thata uniform ring of light emits from the waveguide. Using both lateralextraction features and distal light features allows diffuse light toemit from the lateral surfaces of the waveguide while more focused lightcan be emitted from the distal tip of the waveguide.

Referring now to FIG. 5, light source 11 is transmitting light 11L intocyclo olefin polymer core 30 with refractive index 1.52, fluorinatedethylene propylene (FEP) cladding 32 with refractive index 1.33, and anexternal environment 34 surrounding cladding 32. Light source 11 isassumed to be in air with a refractive index of 1 and a numericalaperture (NA) of 0.55 which corresponds to a half-cone angle, angle 36,of 33.4 degrees. The NA of source 11 is the angle of incidence on thecore when light 11L is coupled in which corresponds to angle 37.Internal light rays 31 initially enter core 30 at the half cone angle of33.4 degrees and are refracted at an angle of 21.2 degrees, internalrefraction angle 39 when they pass into core 30. Internal light 31 thenintersects core-cladding boundary 40 at an angle of 68.8 degrees whichis angle 41. As long as angle 40 is greater than the critical angledetermined by the core and cladding indexes, light 31 will undergo TIRand none of light 31 will be transmitted into the cladding. In this case(n-core=1.52 & n-cladding=1.33) the critical angle is 61.0 degrees.

This ray trace can be worked backwards from the critical angle todetermine the maximum source NA that will still allow for all light toundergo TIR at the core-cladding boundary. If reflection angle 41 is61.0 degrees which corresponds to the critical angle for the selectedcore and cladding, then internal refraction angle 39 is 29 degrees whichmeans that angle 37 must be 47.4 degrees. From 47.4 degrees, the sourceNA is calculated to be 0.74. Therefore, when using the cyclo olefinpolymer/FEP combination, an input source with a much higherNA/Efficiency can be used.

If the source NA is such that all the light coupled into the waveguideundergoes TIR at the core-cladding boundary, then no light ispropagating in the cladding and the environment index does not affectthe waveguide transmission and no light is hitting thecladding-environment boundary. The data in the following table shows howthe critical angle changes at the core-cladding boundary as the claddingindex changes from 1.0 to 1.46 for a cyclo olefin polymer core (n=1.52).This is particularly relevant when designing refractive structures.Knowing the critical angle ahead of time, based on the environment orcladding, the structures can be designed to preferentially leak lightfrom the illumination conduit.

Cladding Index Core-Cladding Critical Angle (degrees) 1.00 41.1 1.1046.4 1.20 52.1 1.30 58.8 1.40 67.1 1.417 68.8 1.42 69.1 1.44 71.3 1.4673.8

When using FEP as a cladding with cyclo olefin polymer, the criticalangle is smaller than the angle from the 0.55NA (68.8 degrees). If nocladding is used, at the index of 1.417 and higher, the critical angleequals to the input angle causing light leakage because TIR is notmaintained. Moreover, the combination of a cyclo olefin polymer corewith FEP cladding allows the use of an input source with NA exceeding0.55. The input source would enable greater light capture from a sourcedue to the larger acceptance angle and provide more light through theillumination conduit assuming constant transmission efficiency.Understanding the critical angles of FEP and open environment,structures can be designed more accurately to extract the light from theillumination conduit.

Any suitable cladding materials such as FEP can be applied to centralportion 12A of suction tube 12 through methods such as manual orsemi-automated shrink-application of oversized FEP with a heat gun orfocused heat from a hot-box nozzle, leveraging FEP's characteristicshrink ratio. Any other technique of a cladding such as FEP may be usedsuch as applying a liquid coating or vapor deposition of FEP to centralportion 12A or any other suitable surface to be clad. Suction tube 12with integrated cladding 15 can then have illumination waveguide 14insert-molded (via conventional high-volume injection molding) andwaveguide 14 will able to maintain total internal reflection. Use ofcladding 15 between suction tube 12 and illumination waveguide 14enables the suction tube to be formed of any suitable material such asmetal or plastic. The choice of the plastic material for the suctiontube needs to be such that the index of that material is below 1.42 foruse with a waveguide having an index of 1.52 to maintain thedifferential at the interface of the suction tube and the waveguide.However, use of plastic may create challenges with injection moldingprocesses which require relatively high temperatures and pressuresinside of the molding cavity. Alternatively the device can bemanufactured such that illumination waveguide 14 is formed with aninternal lumen with no additional suction conduit running through it.The challenge posed by this approach is the potential light transmissionefficiency losses stemming from evacuating biological material (blood,etc) through the lumen and making contact with the internal surface ofthe illumination waveguide lumen throughout the procedure.

Cladding with an index of 1.33 shows no light transmission dependence onthe refractive index of the surrounding environment or the claddingthickness when used with an illumination waveguide having a refractiveindex at or near 1.52. For a cladding with an index of 1.33, the lightcoupled into the illumination waveguide is constrained to the core dueto total internal reflection at the core-cladding interface. Thus, thereis no light propagating through the cladding, making thecladding-environment boundary condition a negligible factor intransmission. Teflon FEP with an index of 1.33 used as a claddingmaterial with a cyclo olefin polymer core with index 1.52, shows nodependence on cladding thickness in three representative simulatedsurgical environments.

While preferred embodiments use heat shrink as the cladding over thesuction tube and/or over the waveguide, in other embodiments, a lowindex of refraction polymer may be injection molded or otherwise formedover the waveguide. FIG. 17 illustrates an illumination waveguide 1704having such a polymer 1706 molded thereover. This allows the polymer tominimize light loss from the waveguide, and also allows the polymer 1706casing to be used for attaching to the suction tube or other surgicalinstruments. For example, the two may be bonded together, solventbonded, welded, or otherwise joined together. In still otherembodiments, snaps or other coupling mechanisms may be joined to thepolymer and suction tube forming a snap fitting. Any number of coatingsor claddings may be used in the previous embodiment, or in any of theembodiments described elsewhere in this specification. The coatings orcladdings may be used to enahance total internal reflection, or thecoatings or claddings may be used for to impart desired opticalproperties to the light (e.g. polarize the light delivered to thesurgical field, etc.), or the coatings or claddings may be used toprovide a protective barrier against damage to the waveguide. Multiplelayers of coatings or claddings may be used. For example, a low index ofrefraction coating or cladding may be applied to the waveguide to helpwith total internal reflection, and then a protective layer may bedisposed thereover in order to help minimize damage to the waveguide.

An illumination waveguide formed from material with a refractive indexof 1.46, showed light transmission dependence on both cladding thicknessas well as the external environment. This is a result of introducinglight into the illumination waveguide at an NA of 0.55. Under thiscondition, light enters the core at an angle that is less than thecritical angle of the core-cladding boundary, resulting in lightpropagating into the cladding. Since light propagates through thecladding, the cladding-environment boundary condition (critical angle)is a factor in the light transmission. Due to light propagating throughthe cladding, the cladding thickness also affects the transmission,because as the thickness increases, the rays bounce at the boundariesfewer times as they traverse the length of the waveguide.

Straight waveguide geometry in which the light traversing the structureencounters no bends or radii results in the greatest optical efficiency.However, due to ergonomic constraints or compatibility & management ofessential accessories related to the device such as proximally attachedfiber optic cables and suction tubing, it may be advantageous to designthe proximal light input such that it creates an angle relative to thedistal transmission body of the waveguide structure.

Referring now to FIGS. 6 and 6A, to preserve TIR and maximizetransmission efficiency in illuminated waveguide 51 of suction apparatus50, central portion 52 between light input section 54 and illuminatedwaveguide body 55 should be curved to form angle 53 between the inputand body as close to 180 degrees as possible. Almost any bend or radiusin the tube will cause some light leakage. However, if angle 53 incentral portion 52 is limited to 150 degrees or greater, the lightleakage is very low and the light transmission efficiency is maximized.Where angle 53 is less than 150 degrees, light leakage may be reduced byreducing or otherwise controlling the divergence of the light within thewaveguide or by using any other suitable technique.

The shape of illuminated waveguide 51 morphs or cylindrically “sweeps”or “blends” from a solid cylindrical input, input section 54 into acircular hollow tube of waveguide body 55. Waveguide bore 56 mayaccommodate any suitable surgical tools such as suction tube 58.Suitable surgical tools access waveguide bore 56 through access opening59. As discussed above, light exits waveguide body at or near distal end60 with the majority of light exiting through distal surface 61. Distalsurface 61 may be flat or it may any other suitable simple or complexshape. Distal surface 61 may have any of the surface features disclosedherein for extracting and directing light to a field of illumination.

As the cross sectional area of illuminated waveguide 51 increases alongthe light transmission path from section 63 of input section 54 tocentral section 65, to distal cross-section 67 near distal end 60, theNA of the illumination waveguide increases, thus increasing the lightdivergence as light emerges from the distal end of the illuminator. TheNA can also be influenced by bends. It may be possible to counter-bendto adjust the NA. Other techniques for controlling the NA of thewaveguide may also include molding or machining features into thesurfaces of the waveguide. The concepts illustrated above can also bemanufactured as two halves that are over molded around any suitablesurgical tool such as suction tube 58. FIGS. 6A-6C illustrate variouscross-sections of the waveguide in FIG. 6, and FIG. 6D highlights thearea surrounding opening 59. Thus, in the embodiment of FIG. 6B, asuction tube 1610 is disposed in the concave saddle portion 1604 of thewaveguide 1602 as seen in FIG. 16. Optical cladding 1606 such as heatshrink tubing is disposed circumferentially entirely around the suctiontube 1610, and then another layer of optical cladding 1608 such as heatshrink is dispose entirely around the circumference of both waveguide1602 and suction tube 1610. A portion of the cladding on the suctiontube contacts a portion of the outer cladding where no waveguidesurrounds the suction tube. Additionally, in this embodiment, the innersaddle has a first radius of curvature and the outer surface has adifferent radius of curvature (here larger than the inner radius ofcurvature). Alternative embodiments may have other combinations of radiiof curvature.

Referring now to FIG. 7, disposable illuminated waveguide 70 can besupplied as a stand-alone device. Various suction devices or othersuitable tools such as suction tool 71 can be inserted though centralbore 72, the working channel of the illumination waveguide. A connectioncould be constructed between waveguide 70 and a surgical tool such assuction tool 71 that would allow the waveguide to be secured to varioussuction devices, enabling both waveguide 70 and suction tool 71 to bemanipulated as a single unit. This concept can be applied to otherdevices that would fit through central bore 72 such as drills, etc.Additionally, illuminated surgical apparatus 74 lends itself to dynamicpositioning of the waveguide 70 relative to any surgical tool insertedin central bore 72, such as suction tool 71. For example, the user couldrotate the illuminator about the suction device as in rotation 75, aswell as telescope illuminator along the length of the suction tube alongpath 76, repositioning or expanding or contracting illumination field 77as needed during the procedure.

An alternative approach involves splitting the solid input circle orellipse such as input 78 of FIG. 7 and split input 80 is formed as inFIG. 8 in which half of input light 11L is directed to one half of theinput, arm 82, and the other half of input light 11L is directed to thesecond half of the input, arm 83. Here, arms 82 and 83 come together ina generally rectangular cross-section as input 80 to engage fiber opticcable 11C. However, input 80 can have circular cross-section withsemi-circular arm(s), elliptical or multi faceted for better mixing oflight. Inputs 78 and 80 may be hollow or tubular and may also be shapedto operate as a lens or may include a plurality of lenses. Theconfiguration could also have FEP cladding strategically applied to oneor more areas of each arm to preserve TIR. To enable proper function ofthe light extraction features, holes, or other suitable shapes could becut into the FEP or other cladding, enabling a desired balance of TIRpreservation and suitable light leakage from specific zones of thedevice. In the embodiments of FIGS. 6, 6A-6D, and FIG. 7, a fiber opticcable may be coupled to the input portion of the waveguide therebyallowing light from an external light source to be delivered from thelight source to the waveguide. The fiber optic cable may be releasablycoupled with the light input portion of the waveguide, or the fiberoptic cable may be a single piece fixedly coupled with the light inputportion of the waveguide and integral therewith (e.g. by overmolding thefiber optic cable with the light input portion of the waveguide). Theintegrated fiber optic cable, or the releasably coupled fiber opticcable may be used with any of the waveguide embodiments disclosedherein. The integrated fiber optic cable or the releasable fiber opticcable may also be used in any of the other embodiments disclosed herein.

During fabrication, particularly injection molding, various artifactsmay be formed in or on an optical part that may result in unpredictableperformance of the optical part. Features such a gate scar, injector pinmarks, parting lines, molded-in stress and any bends or sharp edges maycreate irregular and unpredictable output light patterns. To correct anirregular light output pattern the output surface of the waveguide maysimply be roughened which will diffuse the light output. Roughenedoutput surfaces cause significant efficiency loss and raise the outputangle of the light. An alternative approach may be to create a patternthat projects multiple overlapping images of the defect pattern whichwill result in uniform illumination while minimizing efficiency loss andoutput angle. This can be achieved with a lens array on output surfacesuch as lens array 24 of FIG. 2.

The design of a lens array for the input or output of an illuminationwaveguide should consider the focal length of the lenses, the quantityof lenses in the array, any suitable patterns for the array, and thespacing between the lenses. The lens focal length of the lenses needs tobe selected to minimize diffusion, and to maximize the radius of thelenses of the array. The lens diameter should also consider the toolingto be used to create the lenses. Tool marks left or created by thetooling should be a small percentage of the diameter of the lenses.Similarly, making the lenses too small makes them difficult tomanufacture and diffuses the light output. If the lenses are too large,there will be too few overlapping images and the resulting light patternwill not be uniform.

Incoherent and uncollimated light is going to diverge due to thegeometry and refractive index of the waveguide; any divergence added bythe lens array needs to be considered. Divergence of five to 10 degreesdue to the lenses would be selected to maintain output light divergenceclose to the inherent divergence of the waveguide.

Lens array pattern is also important. The lens array pattern is abalance between manufacturing complexity and lens spacing. Hexagonallenses provide minimal inter-lens spacing and minimal wasted space whilemaintaining light projection characteristics similar to sphericallenses. A rectangular lens array pattern may be selected of a square orrectangular spot pattern is desired. Similarly, a rectangularillumination pattern may be produced by varying the lens pitch betweenthe X and Y dimensions in the plane of the output face on which thelenses are formed. For example, additional microstructure features canbe added to the distal end of an illumination waveguide to optimizecontrol of the illumination pattern as well as to homogenize the lightoutput field. Anti-reflection features, typically diffractive in natureand sub-micron in size, can be added to the input and output faces ofthe illuminator to reduce normal Fresnel reflection losses. The featuresof the waveguide, such as curves, bends, and mounting features, cancause undesired reflections, light leakage, glare, and non-uniformoutput patterns resulting in poor performance. Adding microstructurefeatures which may be refractive or diffractive on or near the distalportion of the illumination waveguide can potentially provide betterlight uniformity and or to bias the divergence or convergence of theillumination pattern as well to homogenize the light output of theillumination field. Features or tapering of the waveguide can also beadded to the outside of an illumination waveguide to control theillumination output. Furthermore, micro lenses such as lens 78L or othermicropattern structures can be added to an illumination waveguide inputsuch as input 78 to better control the input beam shape or other lightinput characteristics. The light input arm can be round, square or multifaceted to provide a better mix of the light.

The waveguide can be made in various shapes or cross sections. Currentlypreferred cross-sectional shapes are round, elliptical, or hexagonal.Other cross-sectional shapes such as rectangles, triangles, or squaresare possible. However, generally regular surfaces of the waveguide, aswell as odd number of surfaces may cause a secondary pattern at theoutput. This pattern would manifest as bright and dark spots. Crosssections resembling even numbered higher order polygons such as thehexagon are currently preferred. As the number of faces in thecross-section increase, these cross sections would approach a circle,such a device design would potentially complicate manufacturingprocessing (such as injection molding), thereby increasing costs.

The illuminator can be tapered to increase or decrease its cross sectionas light travels from the input to extraction zones. Tapering biases theNA, causing either a tighter output spot (for increased area at theexit) or a larger more diffuse spot (decreased exit surface area,breaking TIR).

For an illuminated suction device, in many surgical applications, thereis a need for circumferential illumination around the device. Theillumination may need to be uniformly circumferential or delivered in anoff axis orientation for most of the lighting to orient anterior to theretractor.

Referring now to FIGS. 9 and 10, handle 93 of illuminated suction device90 can be used to preserve TIR within illumination waveguide 94 throughcreation of air gap 91 (n=1.0) around waveguide 94. The design of thehandle structure could include a portion that partially or fully coversthe length of waveguide 94 to create the desired air gap. Features suchas standoffs 93X can be molded into the surface of the handle in contactwith the illuminator and need to be located in optical dead zones (zoneswhere there is little or no TIR) to create a gap between components andminimize light leakage through the contact points. A similarconfiguration may be formed between suction tube 92 and illuminatedwaveguide 94, air gap 95 can be formed without standoffs based on thedesign tolerance between the ID of the illuminator and OD of the suctiontube or with one or more standoffs such as standoff 92X or standoff 94Xor any suitable combination. The air gaps between the handle/waveguideand/or wavguide/suction tube may be used in any of the illuminatedsuction apparatus embodiments disclosed herein.

The divergence of light output from illuminated waveguide 94 can becontrolled by permitting all or a portion of distal casing 96 to slidealong axis 97 over the illuminator. The user can slide the tube downover the illuminated waveguide 94 to reduce the divergence angle andreduce the divergence of light 99L.

Referring now to FIG. 11, the design of handle 93 must accommodate asuitable routing and termination of the suction channel and solid-stateilluminator such that a suction flow control hole H is presented to theuser in an ergonomically favorable position. Based on the way a user isexpected to hold and manipulate an illuminated suction apparatus and theflow pattern of evacuated material from the patient, hole H may bepresent at or near the top surface 98 of the proximal handle. This canaccomplished by forming handle 93 with at least two parts such as topsection 93T and bottom section 93B. In addition to providing a shieldfor and proximal terminus for the illuminated waveguide 94, top handleportion 93T also contains suction flow control hole H. Suction flowcontrol may also be provided by a valve or other similar apparatus thatenables controlled adjustable suction. The top and bottom handleportions are sealed, with the bottom portion 93B creating a chamber incommunication with proximal termination 92P of suction tube 92.Evacuated debris can be kept from flowing through to vacuum tube conduit93P and out of hole H based on the geometry of the chamber 100 andpathway to flow control hole H. Alternatively a “strainer” or “filter”such as filter 102 may be included in handle 93 to capture any solid orliquid debris and prevent the debris from making their way out throughhole H. Features in handle 93 could also allow the user to disassemblethe top and bottom portions to clear any collected debris. The suctioncontrol mechanism may be used in any of the embodiments disclosedherein.

While the concepts presented thus far focus on a completely disposablenon-modular device, alternative architectures are possible including thefollowing:

a. Disposable suction tips (varying French sizes & styles such asyankaeur, etc.) that integrate with a disposable device through a“quick-connect” attach & detach scheme.

b. Disposable illumination sheaths such as waveguide sheath mayaccommodate any suitable surgical instrument such as for example, adrill, burr or endoscope which is encased, enclosed or otherwisesurrounded by optical waveguide sheath. Illumination sheaths can bevarious materials such as flexible silicone.

c. Disposable distal suction tips or other implements (nerve probes,etc) can also be integrated with a reusable proximal illuminatorcontaining a traditional fiber optic bundle. This would enable rapid tipstyle exchange without the need to unplug cables. This approach alsoprovides a means of unclogging trapped evacuated material.

d. Reusable proximal handles with removable single useilluminators/suction tubes. Enables easy change-out of devices withoutneed to unplug cables.

Referring now to FIG. 12, suction lumen 108 may be formed in suctionelement 109 that may be formed around an illuminator such as waveguide110, as shown in illuminated suction apparatus 111. This configurationwould allow for output light 112 to exit from a cylindrical source suchas waveguide 110 without the shadowing caused by having a centralillumination tube coaxial to the illuminator.

The routing of the suction conduit through the illuminator can be variedto optimize the illumination output and balance ergonomicconsiderations.

Referring now to FIG. 13, illuminated suction apparatus 116 isconfigured to enable suction tube 118 to be strategically routed throughillumination waveguide 120 at angle 121 such that (1) proximal exposedend 118P is at the top of the device where the suction control functioncan be more readily accessed by the user; and (2) distal end 118D of thesuction tube emerges from the bottom of the device below illuminationoutput 122, providing optimized lighting of the surgical site from abovethe suction tube. In this configuration the suction tube changes lighttransmission paths through the illumination waveguide by introducingreflective surfaces which more thoroughly mix the light. It is possibleto maintain the efficiency by using high reflective coatings, air gapsand cladding such as cladding 123. However, the added reflectancesurfaces of the suction tube may cause the NA to increase.

Rotationally symmetric illuminated suction devices such as illuminatedsuction apparatus 116 may produce circumferential, uniform light outputwith strategic positioning of the suction tube that mitigates shadowingfrom the suction tube protruding from the distal surface of thewaveguide. Light traversing the illuminated waveguide may havechallenges with secondary reflectance surfaces, thus widening the lightoutput pattern. Illuminated suction apparatus 116 is also expected tohave a very large NA.

Illumination waveguides such as waveguides disclosed above may also bemade malleable out of material like silicone. This can be useful to“pull over” an instrument like suction tube. The illumination waveguidecan be made of a malleable material such as silicone allowing it to bepulled over a rigid suction tube, potentially lowering cost.Alternatively the malleable illumination waveguide material can beformed over a deformable suction tube structure, or a deformablestructure that contains selective strength members (beams, etc). Thiswould enable dynamic shaping of the suction tube to various desiredshapes suited to the clinical application.

The illumination waveguide can be fabricated with materials of varyingindices in a “stacked” or “composite” structure to shape and control thelight output.

An alternative approach involves splitting an illumination waveguidewith a solid light input with a circular or elliptical cross-section,routing and re-combining the waveguide into the original startinggeometry. An illumination waveguide can then be molded over an internalsuction tube. Alternatively, the suction tube in this configurationcould run alongside the spit illuminator geometry.

If the cross section area is maintained (that is, distal and proximalends on either side of split have same cross section, the intermediateshape of the waveguide can be manipulated. In the configuration listedabove, there should be no significant loss of efficiency or change inNA. Thus, the input and output light patterns should be very similar inshape and intensity.

FIG. 29 illustrates yet another embodiment of an illuminate suctionapparatus 2902. The suction apparatus 2902 is a single molded piece 2904that functions both as a suction tube and also as a waveguide. Themolded piece 2904 is an elongate tubular structure having a lumen 2906extending through the molded piece 2904. Thus, the molded piece 2904 maybe used as a waveguide to transmit light distally by total internalreflection, and the lumen 2906 may be used as a suction tube to removefluid and other debris from a surgical field. Light exiting the distalface 2910 illuminates the surgical field, and the distal end 2912 of thelumen is used to suction fluid and debris. The distal end 2912 of thelumen and the distal face 2910 may also be offset from one another andin preferred embodiments, the distal face 2910 is more proximal than thedistal end 2912 of the lumen. Vacuum may be applied to the lumen 2906using standard connectors and fittings, and light may be input into thewaveguide using techniques known in the art. This embodiment has certainadvantages such as allowing it to be molded as a single piece, and doesnot require a separate suction tube.

FIGS. 18A-18B illustrate another exemplary embodiment of an illuminatedsuction apparatus 1802. The apparatus 1802 includes an optional pistolgrip handle 1804, a main handle 1806 formed from right and left handlesections 1806A, 1806 b, a suction tube 1816, a non-fiber optic opticalwaveguide or illuminator 1820 (best seen in FIG. 18B) for emitting light1818, an optical cladding 1812, optical connector 1810, and vacuumfitting 1808. FIG. 18B illustrates an exploded view of the illuminatedsuction apparatus 1802.

All or a portion of the suction tube tip may be modular such that asuction tip may be easily removed from the device and substituted withanother suction tip depending on the anatomy being treated or theapplication (e.g. suction only, suction with electrical stimulation,etc.). Thus, various low profile tips may be provided with theilluminated suction device. The tips may be releasably coupled to therest of the device using any number of quick release mechanisms such asbayonet fittings, threaded fittings, snap fits, detent mechanisms, etc.

FIG. 19A illustrates a perspective view of the illuminated suctionapparatus 1802 in FIGS. 18A-18B. The distal portion of the suction tube1816 has an enlarged or bulbous head region 1824 to help prevent causingtrauma with tissue during use. Additionally, suction holes 1826 may bedisposed circumferentially around the outer surface of the suction tube1816. The distal end of the suction tube may also have a suction hole1828 for suctioning blood or other fluid and debris from the surgicalfield. The distal tip of the optical waveguide may include surfacefeatures 1822 for extracting and directing light to the surgical field.In this embodiment, the surface features form an array of lenses likethose previously described above. Any of the surface features describedherein may be used on the distal tip or on an outer surface of thedistal region of the optical waveguide to extract and direct light tothe surgical field. Some embodiments may have extraction features suchas prisms, facets, lenses or other extractation features on an outersurface of the waveguide so that light is extracted from the outersurface of the waveguide and directed radially outward andcircumferentially from the outer surface of the waveguide. The waveguidemay be coated or clad with a layer of optical material to prevent lightfrom leaking out. Exemplary cladding includes low index of refractionheatshrink materials. Air may also be used as is discussed below. FIG.19A also illustrates the vacuum fitting 1808 which may be a standardbarbed fitting, quick disconnect, or other fitting known in the art toallow the suction tube 1816 to be fluidly coupled to a vacuum source.The optical fitting 1810 may be any standard optical fitting such as anACMI coupler to allow the optical waveguide to be optically coupled withan external light source. In other embodiments, the optical fitting 1810may not be used, and the light source may include an LED or other sourceof light disposed in the handle 1806 or otherwise coupled to theilluminated suction apparatus 1802. In still other alternativeembodiments, the source of light such as an LED may be disposed adjacentthe distal tip of the optical waveguide.

FIG. 19B illustrates an alternative embodiment of an illuminated suctionapparatus 1802 that is similar to the previous embodiment with the maindifference being that the distal portion of the suction tube 1816includes radially extending fins 1830 that form a whisk-like basket onthe distal portion of the suction tube. The fins in the basket preventtissue from being drawn into into the suction holes 1826 causingblockage. The fins may be fixed to the suction tube or they may beradially expandable with adjustable size. In some embodiments, the finsmay be conductive and some or all of the fins may also act as electrodesto electrically stimulate the tissue.

FIG. 19C illustrates a cross-section taken along the line C-C in FIG.19B. It illustrates a distal portion of the illuminated suctionapparatus proximal of the lenses and distal tip of the opticalwaveguide. The optical waveguide 1820 forms a C-shaped structure havinga concave inner surface that is shaped to match the outer surface of thesuction tube 1816, thus the concave region forms a saddle that receivesthe suction tube 1816 in order to minimize profile of the assembly.Additionally, the optical waveguide flares outward and is at leastpartially, or fully wrapped around the outer circumference of thesuction tube, and thus light emitted from the optical waveguide willcircumferentially illuminate an area around the suction tube. Thus thewaveguide may have a cross-sectional area that changes, here increasing,while in other embodiments the cross-section may decrease, or it mayremain constant. The cradle 1814 also has ledges which engage theoptical waveguide to prevent or minimize direct contact between theoptical waveguide and the suction tube. Preferably, an air gap isdisposed therebetween. The air gap helps promote total internalreflection of the light passing through the optical waveguide. Contactbetween the optical waveguide and adjacent structures such as thesuction tube result in light loss which reduces transmission efficiencyof the optical waveguide. Additionally, the outer shield or cladding1812 similarly engages ledges on the cradle to minimize or preventdirect contact between the outer cladding and the optical waveguide byforming an air gap therebetween. In some embodiments, it may bedesirable to provide a barrier that prevents blood or other fluid fromwicking up the suction device along the air gap. The barrier may be anO-ring, adhesive, or any other material disposed between the waveguideand suction tube, or anywhere else where there is a gap for fluid toflow through such as between the waveguide and the outer shield. Thebarrier may be placed anywhere along the device such as at the distaltip, or more proximally to prevent the fluid from wicking. The outercladding is preferably a molded elongate cap element that is placed overthe optical waveguide to prevent blood or other fluid and debris fromcontacting the optical waveguide. It is preferably formed from a polymerhaving a low index of refraction. The closer to an index of 1 (the indexof refraction for air), the better. In some embodiments, the cap maydirectly contact the optical waveguide and light loss is minimized dueto the refractive index of the cap. In still other embodiments, insteadof the cap, only a layer of air cladding is disposed over an outersurface of the waveguide.

FIG. 19D illustrates a cross-section of the illuminated suctionapparatus 1802 taken along the line D-D in FIG. 19B. It illustrates aportion of the illuminated suction apparatus that is more proximal thanin FIG. 19C, and closer to the handle 1806. It shows that the opticalwaveguide 1820 is cylindrical. Thus, it is clear that the opticalwaveguide has a cross-section which changes from the proximal end towardthe distal end. In this embodiment, it changes from the roundcylindrical region to wider the C-shaped distal region. Also, it isclear that thickness decreases distally along the optical waveguide.FIG. 19D also illustrates the cradle 1814 with a channel 1902 havingcorners that engage the optical waveguide 1820 at point contacts 1904 orwith minimum contact area.

FIGS. 20A-20C illustrate various partial cross-sections of theilluminated suction apparatus 1802 in FIG. 19B. In FIG. 20A, a portionof the handle 1806 has been removed to illustrate the air gap 2002 thatsurrounds the optical waveguide 1822 in the handle region, as well asthe air gap 2004 that is circumferentially disposed around the opticalwaveguide as it enters the optical fitting 1810, here an ACMI adapter.Standoffs 2006 formed from ribs in the handle have minimum contact withthe optical waveguide and help provide support to the optical waveguideso that the air gap may be maintained. FIG. 20B illustrates a partialcross-section taken along the line B-B in FIG. 20A and more clearlyillustrates the air gaps 2002, 2004 surrounding the optical waveguide1820. Additionally, ribs 2008 in the cradle 1814 also form standoffsthat help maintain an air gap 2010 between the optical waveguide 1820and the suction tube 1816. FIG. 20C illustrates a partial cross-sectionof the illuminated suction apparatus 1802 with the cladding layer 1812removed.

FIG. 21 illustrates a perspective view of the embodiment in FIG. 19Bwith the cladding and the optical waveguide removed. This viewhighlights the cradle 1814 which completely surrounds a proximal portionof the suction tube 1816 and only partially surrounds the suction tubetoward the distal end thereof. Additionally, a ledge or shelf 2102 formsstandoffs that support the optical waveguide, thereby helping to providean air gap that surrounds the optical waveguide.

FIG. 22 illustrates the suction tube 1816 disposed in the cradle 1814 ofthe embodiment in FIG. 19B. It more clearly illustrates the ledge 2102which supports the optical waveguide. FIG. 23 illustrates the suctiontube 1816. It has a bent distal portion that is shaped so that thehandle may fit comfortably in the operator's hand while allowing the tipto be easily inserted into the surgical field. Any shaped may be used onthe suction tube depending on the anatomy being treated. The presentembodiment and shape may be used in general surgery procedures, as wellas other procedures. In still other embodiments, the suction tube may beformed from a malleable material so that the operator may bent thesuction tube to any desired shaped. In still other embodiments, thesuction tube may be conductive and act as an electrode to delivercurrent to tissue in the surgical field. In still other embodiments,electrodes may be coupled to the suction tube. Any of the electrodeconfigurations described below may be used in this embodiment.Additionally, the suction tube may be coated or covered with a layer ofinsulation to prevent current from flowing out of unwanted areas of thesuction tube. FIG. 24 illustrates the cladding 1812. As previouslydescribed, it preferably is an injection molded elongate polymer elementhaving an outer surface 2402 that is formed into a C-shaped component sothat edges 2406 may be placed into engagement with the standoffs on thecradle to minimize contact therebetween. Additionally, the concaveregion 2404 may be sized and shaped to match and receive the opticalwaveguide while maintaining an air gap therebetween if desired, or thecladding may directly engage the optical waveguide. Preferredembodiments are formed from a material having a low index of refractionin order to prevent or minimize light loss between the cladding and theoptical waveguide where the two components contact one another.

FIG. 25 illustrates an exemplary optical coupling 1810 that may be usedwith any of the illuminated suction embodiment described herein. Itpreferably is compliant with other ACMI optical couplings. The outersurface 2502 may be optically coupled with an external light source. Theinternal channel 2504 is sized to receive the optical waveguide. Ribs2506 may be disposed in the internal channel to minimize contact betweenconnector and the waveguide thereby allowing an air gap to be formedaround the optical waveguide which helps to minimize light loss.

FIGS. 26A-26B illustrate the right 2602A and left 2602 b halves of thehandle 1806. The outer surface may be textured so that the operator caneasily grasp the handle. Additionally, the handle 1806 may have anengagement mechanism 2604 such as snap fittings or other mechanism forreleasably or fixedly coupling the optional pistol grip handle with themain handle. FIG. 27 illustrates the optional pistol grip handle 1804which has a central channel 2704 for receiving the main handle 1806.Cooperating snaps or other engagement mechanisms 2702 may be disposed onthe pistol grip for releasably or fixedly engaging the main handle withthe pistol grip handle. The pistol grip handle may have texturing orother surface features 2706 to facilitate grasping by the operator.

In any of the embodiments described herein, the light input may becoupled to a proximal portion of the optical waveguide using a number oftechniques. For example, in FIG. 28A, the light input may be a singlelight pipe 2802A which is received in a receptacle 2806A in thewaveguide 2804A. The light pipe 2802A may then be bonded in positionusing an index matching optical adhesive. In other embodiments, thewaveguide may be overmolded around the light pipe, thereby forming asingle integral piece. In FIG. 28B, the light input 2802 b may be abundle of optical fibers 2808 b which are received in the receptacle2806 b of waveguide 2804 b. The fibers may be bonded as describedpreviously, or the overmolding processing may be used. This light inputmay be referred to as a pigtail.

FIG. 28C illustrates a single optical light pipe 2802 c which flaresoutward 2810 c to match the width of the optical waveguide 2804 c. Thishelps spread the light along the width of the waveguide, thereby moreevenly distributing the light. FIG. 28D illustrates a similar embodimentthat uses a bundle of fibers 2808D in the input 2802D instead of asingle light pipe. The fibers flare out 2810D to match the width of theoptical waveguide 2804D. In any of these embodiments, bonding,overmolding, or other techniques known in the art may be used to couplethe light input to the waveguide.

FIGS. 31A-31B illustrate still another exemplary embodiment of amalleable and illuminated suction device. The suction device may have asuction tube 3106 that generally takes the same form as any of thepreviously described suction tubes. However, in this embodiment, thesuction tube 3106 is malleable and thus it may be bent in any directionin order to direct the suction to a desired position in the surgicalfield. Additionally, if the suction tube acts as an electrode or haselectrodes disposed on it, bending the suction tube also helps to directelectrical current to a desired position in the surgical field. Awaveguide 3102 that may take the form of any of the previously describedwaveguides may be coupled with the suction tube. A flexible light input3104 maybe coupled with the waveguide. The flexible input 3104 may takethe form of any of the previously described light inputs, including thepigtail described above. In FIG. 31A, the suction tube 3106 is in asubstantially linear configuration. In FIG. 31B, the distal portion ofthe suction tube has been deflected downward to form a curved tip. Thewaveguide bends with the suction tube, and similarly, the light inputalso flexes with the suction tube. Thus, the suction tube may be bent inany direction without requiring the re-adjustment of the waveguide orlight input cable. In some embodiments, portions of the suction tube maybe rigid to prevent them from being bent, while other portions may bebendable. For example, the distal portion may be bendable, while theproximal portion may remain rigid. Preferably, the bendable portionsmaintain their bent positions until manipulated into another position.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. For example, any of thefeatures disclosed in one embodiment of an illuminated suction apparatusmay be used in any of the other embodiments of illuminated suctionapparatuses disclosed herein. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed in practicing the invention. It is intended that the followingclaims define the scope of the invention and that methods and structureswithin the scope of these claims and their equivalents be coveredthereby.

What is claimed is:
 1. A hand held illuminated suction device, saiddevice comprising: a suction tube having an inner surface, an outersurface, a proximal portion, and a distal portion, wherein the proximalportion is configured to be fluidly coupled to a vacuum source, andwherein the distal portion is configured to remove fluid or debris froma surgical field; and an illumination element coupled to the suctiontube, the illumination tube configured to deliver light from theillumination element to a surgical field.